Testing a new treatment for psoriasis:

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1 Plain language summary of a clinical study (Study ID: LP ) Testing a new treatment for psoriasis: first test of a tablet in patients What is this summary about? This summary is written to inform the public in plain language about the results of a clinical study. A clinical study is research done on people. Such research is designed to answer questions about diseases, treatments, or other factors that can affect our health. The results of a clinical study are described in a detailed report for researchers, health care professionals, and authorities who approve medicines. This is a short summary of that report. Do not just look at this summary The results shown here are from a single study. Many studies are needed to find out if a medicine works and is safe to use. Do not change your current medical treatment based on the results shown in this summary. Always consult your doctor. If you would like to find more detailed information about this clinical study, please look at the table at the end of this summary. IN SHORT Why was this study done? To test a new treatment for people with psoriasis. What was tested? The study treatment a tablet was compared with a dummy tablet. Who took part? 33 men and 3 women with moderate or severe psoriasis. What did the study show? Most of the participants who took the study tablets had improvement in their psoriasis. Few of the participants who took dummy tablets had improvement in their psoriasis. The study tablets had many side effects, especially side effects involving the stomach and gut. The most common side effects were: o o nausea (feeling sick or queasy) diarrhoea 1. When and where was this study done? The study started in September 2016 and ended in July It took place at 7 clinics in Germany. 2. What disease was studied? The participants in this study had psoriasis a common disease that affects 2 to 3 out of 100 people. Psoriasis is a disease in the whole body, and it shows up on the skin. The study participants had a type of psoriasis called plaque psoriasis. Plaques are thick, flaky patches of skin. Plaques are often found on the knees, elbows and back, but they may be found on all parts of the body. Since the disease may be both painful and visible, people living with psoriasis often have a reduced quality of life. Right now, there is no cure for psoriasis. But there are several treatments that can improve the signs and symptoms of the disease. 3. Why was this study done? Researchers wanted to test a new treatment in people with psoriasis. The new treatment was a tablet, taken by mouth. Page 1 of 4

2 Severity score 4. Who took part in this study? Altogether, 36 people with psoriasis took part in the study: 33 men and 3 women between 20 and 61 years of age. Most participants had moderate psoriasis when they joined the study. Participants with severe psoriasis Each study participant took 3 tablets twice every day for 16 weeks. They visited their clinic every 2 weeks. At each visit, the study doctor looked at their skin to see if their psoriasis had improved. The study doctor also looked for any side effects of the treatment. 7. What did the study show? The psoriasis improved for more of the participants who took the study tablets than it did for those who took the dummy tablets. Average severity of psoriasis before and after treatment for up to 16 weeks Before Before After Participants with moderate psoriasis After All of the participants lived in an EU country Germany. 5. What treatments were studied? 2 tablet treatments were studied: LEO 32731, called study tablet in this summary a dummy tablet A dummy tablet looks and tastes like the real tablet but does not have any medical ingredients. New treatments are often compared with a dummy treatment in clinical studies. The study tablet was compared with the dummy tablet to check: if the dummy tablet helped improve the psoriasis if the study tablet helped improve the psoriasis more than the dummy tablet did if the study tablet had more side effects than the dummy tablet This was the main result of the study. More results are included in a detailed report for researchers. The table at the end of this summary shows where to find this report. Leaving the study before the end 19 of the 36 participants (53%) left the study early and did not complete the 16 weeks of treatment: 10 of the 18 participants who took the study tablets left the study early. 8 of these participants left because they had side effects, and 2 left for other reasons. See more about side effects below. 9 of the 18 participants who took placebo left the study early. 5 of these participants left because their psoriasis did not improve, 3 left because they had side effects, and 1 participant left for other reasons. 6. How was the study done? Half of the study participants took the study tablets, and the other half took the dummy tablets. It was decided by chance which treatment each participant received. Neither the participants nor the study doctor knew which treatment the participants received. Page 2 of 4

3 8. What were the side effects? The graph and text below show the side effects that the study doctors believed were caused by the treatments. 24 of the 36 participants (67%) in this study had side effects. More participants who took the study tablets had side effects compared with those who took dummy tablets. Participants with side effects 16 of 18 (89%) Serious side effects 8 of 18 (44%) 1 participant had a side effect that was rated as serious because the participant had to go to hospital. The participant took the study tablets. The side effect was a skin infection on the arm. The study doctor thought the infection might have been caused either by the study tablets or by the participant scratching or picking at the skin. The participant was treated with antibiotics at the hospital, and the infection cleared up. Afterwards, the participant continued in the study. Most common side effects The most common side effects were gastrointestinal, which means related to the stomach or gut. Examples are nausea (feeling sick or queasy), vomiting, stomach ache, and diarrhoea. More participants who took the study tablets had gastrointestinal side effects compared with those who took dummy tablets: 16 of the 18 participants who took the study tablets had 52 cases of gastrointestinal side effects. 4 of the 18 participants who took dummy tablets had 8 cases of gastrointestinal side effects. 9. How has this study helped patients and researchers? This summary only shows the results of this one study. Other studies may show different results. Because around half of the participants left the study before the end, more studies are needed to find out if the study tablets can be used to treat people with psoriasis. Are there plans for further studies? Yes more clinical studies with the study tablets are planned. Page 3 of 4

4 10. Where can I find more information about the study You can find more information about this study in other places, as shown in the table below. A clinical study has a unique identifier (ID) in databases and publications. Please use the relevant ID, if necessary, when you search for more information. Source Website ID LEO Pharma A/S website Development/Clinical-trial-disclosure/Clinical-trialsummaries-and-reports.aspx LP Database NCT Company responsible for this study: LEO Pharma A/S Please any enquiries to: disclosure@leo-pharma.com Study name: LEO for the treatment of moderate to severe psoriasis vulgaris Page 4 of 4

5 Signature Page for TMF v1.0 Reason for signing: Approved Management / Lead Approver Verdict(s) Name: Per Sproegel (PSPDK) Capacity: Medical Date of signature: 27-Jun :12:58 GMT+0000 Electronic signatures made within etmf LEO are considered to be a legally binding equivalent of traditional handwritten signatures.